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Direct Healthcare Professional Communication (DHPC) on Azazitidin 25 mg/ml: letter to healthcare professionals about potential risk of incorrect reconstitution (medication error)

Active substance: azacitidine

The marketing authorization holders of Azacitidin 25 mg/ml would like to inform in agreement with the Federal Institute for Drugs and Medical Devices (BfArM) of the new 150 mg azacitidine presentation on the market and the potential risk of medication errors. Please be advised that the 100 mg presentation is reconstituted with 4 ml of water for injections and the 150 mg presentation is reconstituted with 6 ml of water for injections. The final concentration of the reconstituted suspension is 25 mg/ml, regardless of the presentation.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 257KB, File is accessible